V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21

V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 is an FDA 510(k)-cleared medical device (K132026) manufactured by Mindray DS USA, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2013. Regulation: 8.